Phase 3 Schizophrenia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 55 with a body mass index (BMI) of 35 or below, of any gender, who have given their informed consent and are understood by the investigator to be able to follow the study requirements.
• People who have been formally diagnosed with schizophrenia according to standard psychiatric criteria (DSM-5), confirmed through a structured psychiatric interview.
• People who have had a confirmed diagnosis of schizophrenia for at least one year before entering the trial.
• People whose schizophrenia symptoms (both positive and negative) have been stable for at least the past six months, based on their clinician's assessment or medical records.
• People who are currently living outside of a hospital setting (as outpatients) and have not been admitted to hospital for worsening schizophrenia symptoms in the past six months.
• People who have had a stable living situation for at least the past six months.
• People who have a caregiver, family member, or healthcare worker who has regular contact with them, can provide information about their condition, and is expected to remain involved throughout the trial.
• People whose negative symptom scores on the PANSS scale (a standard psychiatric rating tool) meet specific thresholds at both the screening and baseline visits, with scores remaining consistent between those two visits (confirm with trial site for exact score details).
• People who are able to stop taking their current psychiatric medications before the trial begins, with the rate of stopping to be managed gradually by the investigator.
• People who have no history of violence toward themselves or others.
• Women who are not able to become pregnant (for example, due to menopause or permanent surgical sterilisation), or women who can become pregnant but test negative for pregnancy and are willing to use two approved highly effective forms of contraception.
• People whose genetic profile shows they process a specific liver enzyme (CYP2D6) at a normal or faster-than-normal rate, as confirmed by a specific genetic test before the first dose of study medication.
• People who, along with their caregiver, are considered by the investigator to be reliable and likely to cooperate with all study assessments.

Who may not be able to join:

• People who currently have a major depressive disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, intellectual disability diagnosed before age 14, or addiction to drugs or alcohol.
• People whose schizophrenia symptoms include high levels of excitement, suspicion, hostility, uncooperativeness, or poor impulse control, as measured by specific items on the PANSS rating scale.
• People who score above a certain threshold on a depression rating scale specifically designed for people with schizophrenia (the Calgary Depression Scale for Schizophrenia).
• People who show signs of a movement-related side effect called akathisia, as measured above certain thresholds on the Barnes Akathisia Rating Scale.
• People whose psychiatric symptoms appear to be caused by a substance (such as a drug of abuse or a medication) or by a general medical condition.
• People who have had serious suicidal behaviour within the past year.
• People who have had a substance use disorder (other than caffeine use or cigarette smoking) within three months of screening.
• People who test positive on a urine drug screen for substances including cocaine, amphetamines, cannabis, opiates, benzodiazepines (unless prescribed), barbiturates, tricyclic antidepressants, methadone, or alcohol.
• People who cannot safely stop taking their current psychiatric medications.
• People who have taken the antipsychotic medication clozapine within the past six months, except when it was used at low doses (100 mg per day or less) for sleep.
• People who have had electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the past 12 months.
• People currently receiving long-acting or depot (slow-release injectable) antipsychotic medication, unless enough time has passed since the last dose for the medication to have cleared from the body (confirm with trial site for specific timeframes).
• People with significant kidney problems, including a kidney function measurement (eGFR) below 60 mL/min at screening.
• People with a significant or unstable major medical condition affecting the nervous system, brain, liver, blood, lungs, heart, digestive system, or urinary system.
• People with a history of seizures (although people who had a single fever-related seizure in childhood may still be eligible — confirm with trial site).
• People with significant abnormalities in blood test results or physical examination findings that have not resolved by the baseline visit and that the investigator believes could interfere with participation.
• People whose pre-treatment blood tests show low levels of potassium, calcium, or magnesium below specified thresholds.
• People with an active systemic infection such as Hepatitis B (in most cases), Hepatitis C, HIV, or tuberculosis.
• People who need to take other medications that are known to affect heart rhythm in a specific way (QT interval prolongation), such as paroxetine, fluoxetine, duloxetine, or amiodarone.
• People who require medication that blocks the CYP2D6 liver enzyme.
• People with a clinically significant heart rhythm abnormality on an ECG, including a QTcF interval above 430 milliseconds for males or 450 milliseconds for females.
• People with a personal or family history of a heart condition called long QT syndrome or other risk factors for a related heart rhythm problem called Torsade de Pointes.
• People with a history of heart attack, based on medical history or ECG findings at screening.
• People with a history of fainting (syncope).
• Women who can become pregnant, or men, who are unwilling or unable to use accepted methods of birth control during the study.
• Women who test positive for pregnancy, are currently breastfeeding, or are planning to become pregnant during the study.
• People who have participated in another clinical trial that ended within the past six months, or who have taken part in more than two clinical trials involving experimental medications within the past two years.

Important: Always verify eligibility with the trial site directly before applying.